If It Matters To Women’s Health, It Matters To Health Decisions
Health Decisions is a full-service CRO offering therapeutic and operational excellence for clinical development in all areas of women’s health. Our experience, expertise, site network and relationships with KOLs and investigators enable us to address the challenges of developing products in areas including general gynecology indications, contraception, sexual health, infertility, maternal-fetal medicine, menopause and osteoporosis.
We are the leading full-service women’s health CRO from pre-IND to NDA and beyond
With 28 years of experience in more than 300 clinical trials, Health Decisions is the clinical development partner of choice for de-risking development of women’s health products. We assist with regulatory strategy, program planning, protocol development, phase 1 – 4 clinical trials and NDA submission. Our capabilities include project management, site monitoring, biostatistics, data management, quality management, regulatory services and medical writing. Health Decisions draws on the therapeutic expertise of board-certified ObGyns and the operational experience and expertise of clinical, biostatistical and data-management teams to optimize development of women’s health products for conditions across the lifecycle.
Health Decisions’ experience in women’s health studies includes:
- 28 years of experience designing and conducting studies in women’s health
- More than 100 protocols developed and studies conducted in women’s health indications
- 21 years serving as Clinical and Statistical Coordinating Center for Contraceptive Research for the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
- Extensive experience designing, managing and monitoring large-scale international trials
- Experience at all levels, including senior scientists, PMs and CRAs
- Extensive KOL and investigator relationships
Health Decisions brings extensive experience and expertise to clinical trials of novel therapeutics and diagnostics for health conditions commonly treated by ObGyns. Based on involvement in more than 100 women’s health projects in the last 28 years, the Health Decisions clinical affairs and biometrics groups have extensive experience in development of a wide range of women’s health products. Health Decisions draws on a network of principal investigators at more than 280 women’s health sites, numerous Key Opinion Leaders (KOLs) in women’s health specialties, the expertise of a Chief Medical Officer who is a board-certified ObGyn, and a Scientific Advisory Board with extensive expertise in therapeutics and diagnostics for women’s health conditions. Extensive therapeutic expertise and operational experience in women’s health studies enable us to conduct efficient, high-quality clinical trials in indications including:
- Bacterial vaginosis
- Genital warts
- Menstrual disorders
- Pelvic floor disorders
- Polycystic ovary syndrome
- STIs (CT, NG, TV, HPV)
- Uterine fibroids
- Interstitial cystitis
Just as each type of contraceptive appeals to different women and couples in different life situations, clinical trials of novel contraceptives present different regulatory, design and operational challenges. Health Decisions understands the challenges of protocol development for each type of contraceptive as well as the differing operational challenges in areas including project management, site selection, patient recruitment, informed consent, retention, site management, data management and statistical analysis. Health Decisions has experience and expertise spanning virtually all types of contraceptives, including:
- Female hormonal contraceptives
- Male hormonal contraceptives
- Intrauterine devices (IUDs)
- Long-acting reversible contraceptives (LARCs)
- Vaginal rings
- Contraceptive patches
- Nonhormonal contraceptives
- Emergency contraceptives
- Barrier methods
- Spermicidal gels
- Female condoms
- Male condoms
Health Decisions provides therapeutic and operational expertise and site relationships for clinical development of novel products to address issues in women’s sexual health. This encompasses supporting the development of therapeutics and diagnostics for a variety of indications that compromise women’s ability to participate in and enjoy sexual activity. Such indications include but are not limited to female sexual dysfunction, sexual desire disorders, coital pain, vaginal atrophy, vaginismus and STIs. Etiology of many conditions in sexual health can involve one or more factors ranging from physical and hormonal issues to affective disorders, stress in personal relationships and side effects of common medications such as antidepressants and contraceptives. Selection of clinical endpoints in clinical studies of conditions in sexual health often requires great care.
Potential causes of infertility are many and varied. Either the male or female partner may have an issue that renders conception impossible or highly unlikely. In perhaps one-third of cases, diagnostic procedures identify problems in both partners. Sometimes exhaustive testing fails to identify a cause in either partner. Oligoovulation, anovulation, tubal blockage, endometriosis, polycystic ovary syndrome and uterine abnormalities are among potential issues for women. In male-factor infertility, there may be issues in sperm count, motility, morphology, volume, pH and other factors. As a result, the overall population of infertile couples is highly fragmented. While there are millions of infertile couples, the specific population eligible for any individual study may be small. Thus, planning for each infertility trial must begin with a meticulous review of the protocol and must including determining as precisely as possible just how many couples will be eligible. Health Decisions and our therapeutic advisors and clinical staff, as well as the KOLs and PIs in our site network, understand the challenges of planning infertility studies, recruiting eligible subjects and executing such studies with high efficiency and quality.
Health Decisions understands how to address the unique challenges in clinical testing of investigational products to improve outcomes for indications such as preterm labor, preeclampsia and post-delivery analgesia. Studies in pregnant women present obvious issues in minimizing risks to both mother and fetus while making an accurate determination of safety and efficacy. The field of maternal-fetal medicine, devoted to the management of high-risk pregnancies and medical complications during pregnancy, benefits from improvements in areas such as development of diagnostics for determining risk of pre-term birth and preventive drugs and devices. Health Decisions and our clinical staff and therapeutic advisors understand the issues in conducting clinical trials in pregnant women in areas including site selection, subject recruitment, assessments and safety management. Furthermore, the experienced investigators in our site network understand the important of investigator-patient relationships in subject recruitment, retention and follow-up of this patient population.
Menopause and Osteoporosis
Menopausal and postmenopausal women face many health challenges. Whether natural or induced by chemotherapy, menopause is a trying experience for many women. For some, vasomotor symptoms such as hot flashes produce intense discomfort that may continue for years. Other health issues associated with hormonal changes, including osteoporosis, develop gradually but can present serious risks both to fundamental health and quality of life. In some cases, women also experience significant side effects from today’s standard treatments for osteoporosis and some other postmenopausal health conditions. Women in this population are often open to new treatments and willing to participate in clinical trials of novel products. However, women who have identified any product that provides relief for vasomotor symptoms will hesitate to discontinue the product during a washout period or risk randomization to placebo. Health Decisions, our clinical staff and therapeutic experts understand the challenges of recruitment and retention in studies in menopausal and postmenopausal women. The investigators in our site network provide access to a large patient population that includes women open to new therapeutics for menopausal and postmenopausal conditions.
Other Female Health Issues
Health Decisions defines women’s health to include any health condition that affects women profoundly or disproportionately. This includes issues beyond women-only indications generally treated by ObGyns. In straightforward terms: If it matters to women’s health, it matters to Health Decisions. Accordingly, we conduct trials in indications including migraine, depression, anxiety disorders, eating disorders, multiple sclerosis and rheumatoid arthritis. Many of these indications not only affect fundamental health but also quality of life for millions of women worldwide. We are just as committed to improving health outcomes for women in these as in women-only indications.
Download a fact sheet on Health Decisions’ capabilities in reproductive and women’s health. Download Fact Sheet